Rheumatology International

, Volume 40, Issue 2, pp 263–272 | Cite as

Efficacy and retention rate of adalimumab in rheumatoid arthritis and psoriatic arthritis patients after first-line etanercept failure: the FEARLESS cohort

  • Ennio G. FavalliEmail author
  • Andrea Becciolini
  • Antonio Carletto
  • Fabrizio Conti
  • Giorgio Amato
  • Enrico Fusaro
  • Luca Quartuccio
  • Colin Gerard Egan
  • Andrea Lo Monaco
  • Maurizio Benucci
  • Fausto Salaffi
  • Angelo Semeraro
  • Simone Parisi
  • Fulvia Ceccarelli
  • Ilaria Piazza
  • Rosario Foti
Observational Research


Few studies have compared the efficacy of switching from etanercept to adalimumab in the real-life setting in rheumatoid arthritis (RA) and psoriatic arthritis (PsA). This study evaluated the 2-year retention rate and 12-month efficacy of adalimumab in RA and PsA patients, previously treated with etanercept. RA and PsA patients from 11 Italian Rheumatology Units received adalimumab after first-line etanercept failure. Two-year adalimumab retention rate was calculated by the Kaplan–Meier method and Cox proportional hazard models were developed to examine predictors of drug persistence. Univariate and multivariate logistic regression analyses were developed to examine potential predictors of 12-month DAS-28 remission. The study population included 117 RA (disease duration of 10.1 ± 7.7 years and baseline DAS28-ESR of 4.97 ± 1.3) and 102 PsA (disease duration of 7.1 ± 5.1 years and baseline DAPSA of 24.6 ± 11.8). The 2-year retention rate was 48.2% in RA and 56.5% in PsA patients. Concomitant methotrexate treatment was not associated with increased drug survival in both groups. Similarly, cause of etanercept discontinuation or treatment duration was not associated with retention rate. 12-month remission and low disease activity were achieved, respectively, in 27.3% and 23.9% of RA patients and 27.4% and 23.5% PsA of patients. In multivariate models, etanercept discontinuation due to inefficacy (OR 0.27, 95% CI 1.03–0.73; p = 0.009) and baseline DAS-28 (OR 0.45, 95% CI 0.29–0.69; p < 0.001) remained significant negative predictors of remission in RA patients. No variable was associated with remission in PsA patients. Adalimumab after etanercept failure was highly effective and safe in both RA and PsA patients.


Psoriatic arthritis Rheumatoid arthritis Biological drugs Adalimumab Etanercept 


Author contributions

Study concept and design: EGF, AB; data acquisition; EGF, AB, AC, FC, GA, EF, LQ, CGE, ALM, MB, FS, AS, SP, FC, IP, RF; analysis: EGF, AB, CGE; writing: EGF, CGE; interpretation of results; EGF, AB. All authors were involved in drafting the article or revising it critically for important intellectual content. All authors approved the final version to be submitted for publication.

Compliance with ethical standards

Ethics approval

Ethics committee approval on 15/05/2008 from Gaetano Pini Institute, Milan, Italy (protocol no. 63/08) and written informed consent for the anonymous use of personal data were obtained from every patient, in compliance with Legislative Decree 196/2003. This study complies with the ethical standards laid down in the 1975 Declaration of Helsinki.

Conflict of interest

EGF served as a consultant and/or speaker for BMS, Lilly, Celgene, MSD, UCB, Pfizer, Sanofi-Genzyme, Novartis, and AbbVie. AB served as a speaker for Sanofi-Genzyme, UCB, and AbbVie. AC served as a consultant and/or speaker for BMS, Lilly, Celgene, MSD, Janssen, Roche, Sanofi, Sandoz and Novartis. FaC served as a consultant and/or speaker for BMS, Lilly, Celgene, Pfizer, and AbbVie. LQ served as a consultant and/or speaker for Celgene, Roche, Lilly, AbbVie, and Pfizer. ALM served as a consultant for Sanofi and Roche. MB served as a consultant and/or speaker for BMS, Lilly, Roche, Novartis, Janssen. FS served as a consultant and/or speaker for BMS, MSD, Pfizer, Novartis, and AbbVie. AS served as speaker for BMS, AbbVie, MSD, UCB, Novartis, Sanofi. SP served as consultant and/or speaker for AbbVie, Biogen, BMS, Celgene, Janssen, Lilly, Novartis and UCB. RF served as a consultant and/or speaker for BMS, Lilly, Celgene, MSD, UCB, Pfizer, Janssen, Novartis, and AbbVie. EF, FuC, CGE and IP declared no conflict of interest.


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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Ennio G. Favalli
    • 1
    Email author
  • Andrea Becciolini
    • 1
  • Antonio Carletto
    • 2
  • Fabrizio Conti
    • 3
  • Giorgio Amato
    • 4
  • Enrico Fusaro
    • 5
  • Luca Quartuccio
    • 6
  • Colin Gerard Egan
    • 7
  • Andrea Lo Monaco
    • 8
  • Maurizio Benucci
    • 9
  • Fausto Salaffi
    • 10
  • Angelo Semeraro
    • 11
  • Simone Parisi
    • 5
  • Fulvia Ceccarelli
    • 3
  • Ilaria Piazza
    • 2
  • Rosario Foti
    • 4
  1. 1.Department of RheumatologyASST Gaetano Pini-CTOMilanItaly
  2. 2.Rheumatology UnitAOUIVeronaItaly
  3. 3.Dipartimento di Medicina Interna e Specialità Mediche, ReumatologiaSapienza Università di RomaRomeItaly
  4. 4.Rheumatology UnitA.O.U. Policlinico Vittorio EmanueleCataniaItaly
  5. 5.Rheumatology UnitAzienda Ospedaliera Universitaria Città della Salute e della ScienzaTurinItaly
  6. 6.Clinica di Reumatologia, Dipartimento di Area MedicaASUIUDUdineItaly
  7. 7.CE Medical WritingPisaItaly
  8. 8.UOC di ReumatologiaAzienda Ospedaliero-Universitaria Sant’Anna Cona-FerraraFerraraItaly
  9. 9.SOS ReumatologiaOspedale S. Giovanni di DioFlorenceItaly
  10. 10.Clinica ReumatologicaUniversità Politecnica delle MarcheAnconaItaly
  11. 11.U.O.ReumatologiaASL Taranto-PP.OO.SS. Annunziata Taranto e Valle d’ItriaTarantoItaly

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